Preparing for a FSMA Audit from FoodOnline

A recent article in FoodOnline (an informative online journal you should subscribe to if you haven't already) discusses how Kraft Heinz prepares for FDA FSMA inspections. A few key points brought up in this article are similar to what we have been hearing about from our industry friends about their recent audits.

A summary of what this company's regulatory affairs manager discussed about their company's experiences:

• 'Inspectors are calling these ‘routine FSMA inspections' and are not distinguishing between Preventive Controls and modernized GMP inspections' 
• These audits are generally more focused on high-risk products.
• Auditors had visited 7 of these audits - one full Preventive Controls inspection and six modernized GMP audits.
• Generally there are three inspectors.
• Audits have lasted 1 to 5 days, mostly 4 to 5 days.
• Four of the seven audits included swabathons (100 to 150 swabs), which included Zone 1 (30%), Zone 2 (20%) and Zone 3 (50%).  No zone 4.
• There is a focus on the company's environmental monitoring program including the records and corrective actions on positvie results.
• With regard to verification activities, they are focusing on records including corrective action logs, production schedules, sanitation records, and calibrating inspection equipment records.
• With regard to the Preventive Control plan, inspectors are reviewing the hazard analysis with questions on the justification behind each of the identified hazards.
• There is also a review of the written recall plan.
• Recently there is attention on the supply chain program.
• Review of handling of byproducts used for animal feed, consumer complaint handling, and FSPCA training looking for certificates of completion.

An interesting item in the article is that FDA will want to take photos in the facility, so a company needs to have a policy to address this.  The same goes with photocopying records.

Source: Food Online 
Inside Kraft Heinz's FSMA Inspection Readiness 
Link
By Sam Lewis, associate editor
Follow Me On Twitter @SamIAmOnFood

Breakfast Sausage Recalled Due to the Potential for Metal Foreign Material

A Kansas establishment is recalling 90,000 lbs of RTE breakfast sausage for metal pieces after "another FSIS-regulated establishment that pieces of metal were embedded in a fully cooked sausage product".

Over the past year, there has been an increasing amount of recalls due to foreign objects.  While these foreign objects may not result in any major injuries, the cost of conducting a recall warrants companies putting in more effort in foreign object control.  This goes beyond just having a metal detector installed into the process.

First, many metal detectors do not get the attention they need.  A really nice guide for metal detectors is "The Guide to Reducing Metal Contamination in the Food Processing Industry" published by Safeline.  

X-ray equipment is much more affordable than it once was, and it can pick-up items metal detectors can't, such as glass, hard plastic, stones, etc.  They are even suitable for metal and foil containers.

But detection is just one part of a foreign object control program.  Other important elements include raw material inspection, preventive maintenance, employee training to prevent accidental drops, and controls at ingredient addition steps to prevent foreign material from packaging and inline preventive devices such as magnets and sifters.

All of these systems need to be properly maintained and verified for performance.  Additionally, consumer complaints must be reviewed with an investigation and appropriate corrective action for any foreign material issues.

USDA / FSIS Recall Notice

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-054-2017-release
Armour Eckrich Meats, LLC Recalls Ready-To-Eat Sausage Products Due to Possible Foreign Matter Contamination
Class II Recall 054-2017
Health Risk: Low 

May 24, 2017

Packaged Salad Items Recalled Due to Metal Pieces from Construction

A NY based produce company is recalling salad products due to the potential for metal pieces.  The metal was said to be generated from construction activities. 

Many facilities carryout construction activities while they are producing products.  However, it is critical to protect product from contamination.  Metal pieces can easily be shot over wide areas during construction activities such as grinding and wielding.

BrightFarms is an interesting company.   Based in NY, the company is building huge hydroponic greenhouses in various market areas in order to grow produce locally to supply those markets.  [Story below].

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm559445.htm
Brightfarms Announces Voluntary Regional Recall of Produce Due to Potential Presence of Metal Pieces From Construction
For Immediate Release
May 18, 2017

One Man Dead, A Mom Still Hospitalized after Three Weeks, Both Consumed Contaminated Nacho Cheese Sauce

One woman's story, associated with the botulism in gas station nacho sauce case, highlights the issues for someone with botulism poisoning.  A few hours after eating Doritos drizzled with nacho cheese sauce, she felt fatigue and by the next day, she had blurred vision followed by vomiting and difficulty in breathing.  These symptoms are caused by the  neurotoxin produced by Clostridium botulinum as it grew in the nacho cheese sauce. Once the toxin contaminated food is consumed, "Botulinum toxin causes flaccid paralysis by blocking motor nerve terminals at the neuromuscular junction. The flaccid paralysis progresses symmetrically downward, usually starting with the eyes and face, to the throat, chest, and extremities. When the diaphragm and chest muscles become fully involved, respiration is inhibited and, without intervention, death from asphyxia results". (FDA Bad Bug Book)

There has also been one death being associated with the tainted nacho cheese.  A man had been on life support.  This has not yet been confirmed by State officials.

There are now 10 people that have been affected from eating at this establishment.


Sacramento Bee
http://www.sacbee.com/news/local/health-and-medicine/article150908817.html
Mom put nacho cheese on her Doritos. Three weeks later, she’s still in the hospital.
By Sammy Caiola  scaiola@sacbee.com
May 16, 2017

Meat Processor Recalls Hot Dogs After Receiving Three Complaints for Metal

An Ohio meat processor is recalling 210,000 lbs of  hot dogs after 'the establishment received three complaints of metal objects in the beef frank product package'.


USDA / FSIS Recall Notice
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-052-2017-release
John Morrell and Co. Recalls Beef Frank Products Due to Possible Foreign Matter Contamination
Class II Recall 052-2017
Health Risk: Low May 19, 2017

WA Institutional Food Processor Recalls Food After Learning of Water Contamination Issue

A Washington state establishment which manufacturers food for correctional facilities, senior centers, and county jails, is recalling 319, 000 lbs of food after being notified by the local water authority that the well water used to manufacture their products may be contaminated with hazardous chemicals. This contamination issue also affects the local city's drinking water.

The chemicals, Perfluorooctanesulfonic acid (PFOS) and Perfluorooctanoic acid (PFOA), originated from the local Air Force base where they were used in fire fighting spray.  While these chemicals are above EPA standards, there are no food safety regulations. The EPA classifies these as emerging contaminants.with a limit of 70 parts per trillion.  The wells were found to have 1100 parts per trillion.  The chemicals do not have an acute affect at this level, but the concern is for cumulative exposure where they can cause liver damage, cancer, among other negative health affects.  

It is important to understand where a facility's water comes from and potential contamination issues, even if it is municipal water and/or well water.  Are the wells in areas where there has been past contamination issues?  What is the depth of the well?  How often is the water monitored and what is it monitored for?

UDSA /FSIS Recall Notice
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-053-2017-release
Correctional Industries Airway Heights Food Operations Recalls Frozen Meat and Poultry Products Due to Water Contamination
Class II Recall 053-2017
Health Risk: Low May 20, 2017

Nacho Cheese Sauce Probable Source of Gas Station Botulism Cases

Public Health officials in CA believe the source of the botulism cases that occurred from eating at a gas station to be the nacho cheese sauce product.  Most cheese sauce products are made to be shelf-stable for distribution, but once opened, most products may need to be stored at the proper temperatures (outside of the temperature danger zone) to prevent growth. Much of this depends on the formulation (pH, Aw, preservatives).  They also have to be protected against cross contamination.

It difficult to tell whether these product were not properly formulated or were improperly held,  One could guess that the cheese sauce was not properly stored or handled after opening, allowing for a small amount of contamination to grow.  It may have been transferred from a pouch to a canister or serving trey.  For Clostridium botulinun, intoxication to occur, the organism would need to grow in number to produce sufficient toxin.  The product itself would need to be formulated to allow growth and that product would also need to be held at improper temperatures, most likely in the upper part of the temperature danger zone (70F to 125F).

With a thick product like this, people may assume it is like ketchup or mustard that can be left at room temperature after opening....not unless it was formulated that way.  Generally cheese sauce have a higher pH and Aw.   Another potential issue can occur if these products are modified in any way.  Adding peppers or other raw ingredients can be an issue.  Adding water to the product can also be an issue....such as might be the case if the product thickened up after sitting on the hot bar all day.

Sacramento Bee

http://www.sacbee.com/news/local/health-and-medicine/article149818204.html

Nacho cheese to blame for rare botulism outbreak at Sacramento area gas station

By Sammy Caiola scaiola@sacbee.com
May 10, 2017

Canadian Firm Recalls Frozen Breaded Chicken Products for Potential Staph Aureus Enterotoxin

A Canadian firm is recalling breaded chicken products for Staphylococcus aureus enterotoxin.  Product was distributed in Ontario.  No illnesses have been reported.

The issue with Staphylococcus is that the organism  can grow in the batter if that batter is temperature abused.  As the organism grows to high numbers, it produced a heat stable toxin.  So once there, the fryer used to set the coasting at the manufacturing facility as well as any cooking done in the home by the consumer will not eliminate that toxin.. It is critical (thus a CCP / Process Preventive Control) for facilities to control batter temperature throughout the day.

Food Recall Warning - Various breaded chicken products recalled by Maple Leaf Foods due to a toxin produced by Staphylococcus bacteria

Recall date:May 9, 2017 

Reason for recall:Microbiological - Staphylococcus aureus .

Fresh Bagged Spinach Recalled for Listeria Contamination

A KY company is recalling bags of fresh spinach after being notified by their supplier partner that the spinach may have Listeria contamination.  According to the report, "The products were distributed in North Carolina, Illinois, Kentucky and West Virginia and distributed through retail stores, wholesale and foodservice distributors."

FDA Recall notice
https://www.fda.gov/Safety/Recalls/ucm558398.htm
The Horton Fruit Company, Inc. Issues Voluntary Recall of Fresh Spinach Because of Possible Health Risk
For Immediate Release
May 12, 2017